Colchicine And Dialysis Patients; a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility to progress to a full-scale trial
研究概览
简要总结
Colchicine is an inexpensive drug that has been available for decades. Trials, which excluded patients with kidney disease, showed that colchicine decreased the number of heart attacks and strokes. The investigators cannot be sure if these results will apply to dialysis patients and a clinical trial exploring the effect of colchicine on heart attacks and strokes specifically in dialysis patients is needed. Colchicine may also be beneficial for dialysis patients as it may help arteriovenous fistulas to last longer. An arteriovenous fistula is a connection made between an artery and a vein in the arm, allowing for access to a person's bloodstream as part of dialysis. Sometimes, these connections can get too narrow in some parts, stopping them from working properly. These narrowings can be treated with a balloon inserted into the vein with the help of an x-ray. Balloons coated with a drug called paclitaxel, which works like colchicine, can be helpful, so the investigators think colchicine may help too.
At present, colchicine is often avoided in patients receiving dialysis. Patients on haemodialysis take a number of medications already and have significant comorbidity. Therefore, it is possible that a higher proportion would have difficulty tolerating colchicine. These concerns mean that a large trial assessing the potential benefits of colchicine in this population cannot begin without further data on feasibility.
This feasibility study will establish whether low dose colchicine is tolerated and acceptable to dialysis patients and will help the investigators to plan recruitment to future clinical trials. The investigators will give colchicine to 100 dialysis patients. The investigators will monitor the participants for side effects and see how many continue to take it for the planned period of 3 months. If feasibility is confirmed, there are then strong rationales for large clinical trials exploring the effect of colchicine on both mortality and vascular access outcomes in dialysis patients.
详细描述
This study will include patients on haemodialysis from a single large renal centre.
All participants will receive a low dose of colchicine once a day for 3 months and 2 weeks.
There will be no control group in order to maximize the data on tolerability, in relation to the number of participants recruited. The lack of a comparator arm will not affect this key outcome measure.
Blood will be taken to assess blood count, liver function and creatinine kinase at the start of the trial, at two weeks, and then at monthly intervals. These blood tests will be taken on haemodialysis with no additional venepuncture or visits required.
Patients will be interviewed by telephone on day 2 and then at the time of the monthly blood tests, to ask about any side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anyone who is undergoing haemodialysis.
- •Aged 18 or over
- •Able to give informed consent
排除标准
- •Already taking colchicine for a clinical indication.
- •Taking a drug known to increase colchicine levels.
- •Has a previously documented intolerance of or allergy to colchicine
- •Has a history of chronic liver disease, or abnormal liver function (i.e. ALT > 1.5 x upper limit of normal). Patients with a history of hepatitis are eligible provided these limits are not exceeded.
研究组 & 干预措施
Colchicine
干预措施: Colchicine 0.5 mg (Drug)
结局指标
主要结局
Feasibility to progress to a full-scale trial
时间窗: From enrolment to the end of treatment at 3 months and 2 weeks
Patients approached, screened, and included in the study (consent rate).
Feasibility to Progress to a Full-Scale Trial
时间窗: From enrolment to the end of treatment at 3 months and 2 weeks
Patients who continue colchicine until the end of the study.
次要结局
- Feasibility of data collection(From enrolment to the end of treatment at 3 months and 2 weeks)